Thrive With Type 1 Diabetes 2026

NCT07522866 | Recruiting

• 1 other identifier: 2026P000152
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.

Conditions

Type1diabetes

Keywords

Glycemia; A1C; Sleep

Outcome Measures

Primary Outcomes (2)

• Multidimensional sleep health composite score

  The multidimensional sleep health composite score assesses six domains: regularity, satisfaction, alertness, timing, efficiency, and duration. Sleep regularity, timing, efficiency, and duration will be measured using a non-dominant wrist-worn research-grade actigraph (Ametris CentrePoint Insight Watch) worn 24/7 during the monitoring period. Sleep satisfaction will be assessed using the global score of the 19-item Pittsburgh Sleep Quality Index (PSQI; range 0-21; scores \<5 coded as 1, indicating good sleep). Alertness will be assessed using the Epworth Sleepiness Scale (ESS; range 0-24; scores \<8 coded as 1, indicating good daytime alertness). Each component will be scored according to predefined criteria and summed to create a composite score ranging from 0 to 6, with higher scores indicating better overall sleep health over the 1-week monitoring period at each time point. The composite score (unitless) will be assessed at baseline and post-intervention.

  Baseline and post-intervention (14 weeks from baseline)

• Glycated hemoglobin (HbA1C)

  HbA1C will be measured by the FDA-approved A1C Now Self-Check. HbA1C reflects the average blood glucose level over the preceding approximately 2-3 months and will be reported as a percentage (%). Changes in glycemia will be assessed by comparing HbA1C values measured at baseline and post intervention. Units = percent (%).

  Baseline and post-intervention (14 weeks from baseline)

Secondary Outcomes (2)

• Glucose variability

  Baseline and post-intervention (14 weeks from baseline)

• Time in range

  Baseline and post-intervention (14 weeks from baseline)

Study Arms (2)

Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention Arm

EXPERIMENTAL

Participants will work with a health coach to aim for 7-9 hours of sleep per night, at least 85% sleep efficiency, and less than 60 minutes' variation in bed and wake times.

Behavioral: TranS-C Intervention Arm

Enhanced Usual Care (EUC) Arm

ACTIVE COMPARATOR

Participants will work with a health coach focused on enhanced usual care.

Behavioral: Attention Control Enhanced Usual Care (EUC) Arm

Interventions

TranS-C Intervention Arm BEHAVIORAL

This 12-week cognitive behavioral intervention uses motivational interviewing and behavior change principles, focusing on self-efficacy and action planning. Participants target 7-9 hours of sleep per night, ≥85% sleep efficiency, and \<60 minutes' variability in bed and wake times. Components include sleep education and hygiene, nightly routines, the management of competing activities, sleep environment optimization, lifestyle modifications (e.g., avoiding caffeine and vigorous exercise before bedtime), screen time reduction, basic stress management (e.g., progressive muscle relaxation), and self-monitoring. Following a baseline visit, a research assistant conducts a 60-minute telehealth session via HIPAA-compliant Zoom/Teams, with booster sessions at weeks 4, 8, and 12. Sleep time is adjusted weekly based on sleep efficiency criteria.

Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention Arm

Attention Control Enhanced Usual Care (EUC) Arm BEHAVIORAL

This time- and attention-balanced 12-week condition will focus on enhancing usual care. After the initial baseline visit, the RA for this group will schedule a 60-minute telehealth appointment for the enhanced usual care. Follow-up sessions (weeks 4 and 8) will focus on health perceptions, care plans, and relationship-building rather than sleep promotion. The RA will encourage participants to share their progress and confidence in their self-set goals to foster engagement and retention. Participants may engage in self-initiated diabetes management, which will be tracked using a Diabetes Self-Management Tracking Form.

Also known as: Enhanced Usual Care (EUC)

Enhanced Usual Care (EUC) Arm

Eligibility Criteria

• Age: 31 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 31 to 75 years
• Type 1 Diabetes for at least 1 year
• One or more sleep health dimensions are out of range

You may not qualify if:

• Non-English speaking
• Recent night shift work or transmeridian travel
• Life-limiting illness

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University, Nell Hodgson Woodruff School of Nursing

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

Study Officials

• Stephanie Griggs, PhD, RN, FAAN

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Griggs, PhD, RN, FAAN

CONTACT

404-544-9915; stephanie.griggs2@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 9 months following article publication, with no end date.
• Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in Emory University's data warehouse, but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (link to be provided).

Locations

US (2)